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Indian pharma is focusing on strengthening post-marketing surveillance (PMS) and improving supply chain transparency for over-the-counter (OTC) drugs. This is in a bid to ensure patient safety, improve medicine quality to better manage untoward adverse events and promote safer use of these medicines.
Here India could benefit by adopting best practices from the US, including the implementation of a monograph system, enhancing regulatory compliance and utilize technology to monitor and verify items crucial in combating counterfeiting, said Raghuram Nidavanda, assistant drugs controller, Karnataka Drugs Control department, Belagavi in his thesis submitted to Delhi Pharmaceutical Sciences and Research University for receiving the degree of Master of Pharmacy in the drug regulatory affairs.
In the thesis titled ‘A comparative study of regulatory requirements for OTCs in India and USA’, Raghuram noted the widespread existence of fake OTCs which poses risk to the safety of consumers and the integrity of the market.
In India, the regulatory environment for OTC goods is not as well delineated as it is in the US. The sale of medicines is regulated by the Drugs and Cosmetics Act, 1940, together with later revisions. However, the Act does not provide clear and detailed regulations for the categorization of OTCs. On the other hand, the US has a well-established legal structure through the Food and Drug Administration (FDA), he said.
As per FDA, OTC medications must adhere to particular criteria, to be acknowledged as safe and effective with the directions provided on the label. These products are regulated by the FDA's OTC monograph system, which specifies the ingredients, dosages, formulations, and labeling criteria that are considered acceptable.
The OTC market is now witnessing rapid expansion in the Asia Pacific region. This is attributed disposable incomes, health consciousness, and enhanced accessibility to healthcare services, he stated.
Further, digital health technology is revolutionizing OTC business. Use of package innovations like child-resistant designs, tamper-evident features, and environmentally friendly materials, is increasing its safety and sustainability. Companies are also investigating smart packaging systems that can provide real-time information and reminders to consumers, he said.
Although OTCs offers many growth prospects, it also encounters regulatory obstacles. There is need for uniform quality and safety in the wake to growing self-care medication as OTCs not only give patients more control over their mild diseases, but it also saves money on healthcare costs, stated Raghuram.
The availability of OTC for self-medication in the US healthcare system saved $102 billion a year, including $25 billion in prescription savings and $77 billion in clinical visits. Indian research on the 'Value of OTC in India' found that its availability resulted in yearly savings of around Rs.30,730 crore and improved overall health outcomes, he said.
The comparative examination of OTC regulatory frameworks in India and the US reveals substantial differences, particularly in the approval processes, post-marketing surveillance, and consumer protection. The USFDA system is more developed, with a strong emphasis on safety, efficacy, and consumer information, while India's regulatory environment is still evolving, with efforts to improve but significant gaps remaining. Therefore standardizing regulatory norms on a global scale is crucial, he said.
On a concluding note Raghuram said, “Future research should focus on addressing regulatory gaps, explore the potential of emerging technologies, and foster collaboration to improve the regulatory landscape for OTCs in both countries. By doing so, both nations can work towards a more harmonized and effective regulatory system that ensures the safety, efficacy, and accessibility of OTC products for consumers, stated Raghuram.
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